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Covaxin human trials at AIIMS Delhi: Phase 1 trial of the vaccine will be completed on a total of 100 volunteers in the All India Institute of Medical Sciences (AIIMS). In the first phase, a total of 375 people are to be given vaccine doses across the country.

Highlights

• Covaxin trial in Delhi AIIMS starting on Monday
• ICMR-NIV and Bharat Biotech make vaccine together
• Phase 1 will test 375 people, 100 in Delhi AIIMS
• Volunteers registration started, the first dose can be given today
• Trials in 12 cities of the country including Delhi, Patna AIIMS

Human trial of the first corona virus vaccine Covaxin made in India is starting in AIIMS, Delhi. Principal Investigator Dr Sanjay Rai, who is responsible for the trial, told All India Radio that the registration process has been started. It is expected that some volunteers will be given the first dose of vaccine today. AIIMS Delhi is one of the 12 places in the country where Covaxin is being tried. The sample size here is the largest in the country, so the results will decide the direction of the entire research. Vaccine trials are already underway at AIIMS Patna and Rohtak PGI. The trial process is also starting from today in Goa. Let’s know the big things related to the vaccine trial.

• Covaxin has been formed by Bharat Biotech of Hyderabad in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The codename of the vaccine is BBV152.
• Covaxin is an ‘inactivated’ vaccine. It is made up of corona virus particles that were killed so that they could not infect. Its dose makes antibodies against the virus in the body.
• Covaxin has received approval from the Drug Controller General of India for Phase 1 and Phase 2 trials. A total of 375 people will be tried in the first phase and 750 in the second.
• ICMR has chosen institutes where there is a clinical pharmacology wing and health care professionals with experience in human trials.
• All the details of the trial will be sent to ICMR. At the same time, the data is being analyzed.
• Two doses of vaccine – the first day and the 14th day will be given. The trial will also use ‘double-blind’ technology in which neither volunteers nor researchers will know who is getting the vaccine and who is the placebo.

This can become part of AIIMS trial

• Individuals between 18 and 55 years of age can participate in this randomized, double-blind, placebo-control trial.
• Volunteers should not have any disease. Nor should he have previously been Kovid-19 positive.
• Any healthy person who wants to be a part of the trial can email Ctaiims.covid19@gmail.com. Apart from this, SMS or call can also be made to 7428847499.

The trial in Goa also from today

• A human trial of Covaxin will start from today in a private hospital in North Goa.
• A total of 10 volunteers will be selected whose swab samples will be sent first to Delhi.
• After the reports from Delhi, the actual trial will start from Tuesday.

The ongoing trial of two domestic vaccines

• The Drugs Controller General of India (DCGI) has currently allowed two vaccines for human trials. One of these is Covaxin and the other is ZyCoV-D of Zydus Cadilla.
• In the first phase of the trial, Zydus Cadila will dose up to 1,000 participants.
• ZyCoV-D based on DNA is developed at Vaccine Technology Center (VTC), Ahmedabad.

How long will the vaccine trial take?

• According to the protocol on the clinical trials registry, the first phase will take at least one month.
• The data received from him will have to be presented to the Drug Controller General of India and then the next stage permission will be obtained.
• Phases 1 and 2 may take a year and three months in total. The vaccine will be tried on thousands of volunteers in the third stage.

How will I get approval after being created?

• According to Dr. Inder Maurya, CEO-Founder of Foreign OPD, the vaccine is sent for approval and licensing upon a successful trial.
• In India, its authority is with the Central Drugs Standard Control Organization (CDSCO).
• Safety, efficacy, and production of the vaccine are monitored.
• Normally, a vaccine is further researched before approving it. Even after vaccine approval, its effect is monitored for a few years.